BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT PROFILE PHOX PLUS ANALYZER

    MDR report key: 495633 · Received November 14, 2003

    Report

    Report Number
    1219029-2003-00005
    Event Type
    Death
    Date Received
    November 14, 2003
    Date of Event
    August 1, 2003
    Report Date
    November 13, 2003
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    JGS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON A SERVICE AGREEMENT SALES CALL FROM NOVA, THE INITIAL REPORTER INDICATED THAT THEY HAD A RECENT INCIDENT IN WHICH THE NOVA STAT PROFILE PHOX PLUS ANALYZER REPORTED ERRONEOUS PATIENT RESULTS THAT LED TO A PATIENT EXPIRING. "NOVA BECAME AWARE OF THIS EVENT IN 10/2002 AND THE EVENT OCCURRED IN APPROX 2003 (48 DAYS EARLIER)". THE INITIAL REPORTER STATED THAT THE CASE WAS A DIFFICULT ONE. AT SOME POINT DURING THE PROCEDURE THE SURGEON PERFORMING THE SURGERY IN THE OR QUESTIONED THE REPORTER ON THE STP PHOX PLUS ON ONE SAMPLE BELIEVING THAT THE RESULTS DID NOT MATCH THE CLINICAL PICTURE. THE STAT PROFILE PHOX PLUS ANALYZERS WERE IMMEDIATELY TAKEN OUT OF SERVICE AND ALL BUT EMERGENCY CARDIAC BY-PASS SURGERIES WERE CANCELLED. INITIAL REPORTER INDICATED NO KNOWLEDGE OF TESTING OR EVALUATION OF THE SUSPECT ANALYZERS AFTER BEING TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT PROFILE PHOX PLUS ANALYZER ABG ELECTROLYTE ANALYZER JGS NOVA BIOMEDICAL CORP. STP PHOX PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death